Novartis was created in 1996 through a merger of Ciba-Geigy and Sandoz. Novartis and its predecessor companies trace roots back more than 250 years, with a rich history of developing innovative products. From beginnings in the production of synthetic fabric dyes, the companies that eventually became Novartis branched out into producing chemicals and ultimately pharmaceuticals.
Job Title: Submission Writer
Job ID : 218256BR
Work Location : Hyderabad
Division : PHARMA
1. To author, review and independently manage high quality clinical and safety documents: non registration Clinical Study Reports (CSR), Development Safety Update Reports (DSUR), Clinical Trial Registry Database (CTRD), Risk Management Plans (RMP), Periodic Safety Update Reports (PSUR).
2. Lead for outsourced Narrative projects. Coordinate other outsourced activities in OSM.
3. Core member of Clinical Trial Team (CTT)/ participate in Safety Management Team (SMT).
4. Actively participate in planning of data analyses and presentation to be used in CSRs.
5. Act as documentation consultant in CTTs and SMTs to ensure compliance of documentation to internal company standards and external regulatory guidelines.
6. May act as Program Writer ensuring adequate medical writing resources are available for assigned program and consistency between documents.
7. Act as liaison between CTTs, CSTs and publishing teams to ensure timely delivery of final documents for publishing.
8. Support the development of OSM through participating in OSM initiatives and other related activities.
9. Contribute to development of processes within OSM. May contribute to cross-functional initiatives.
10. Fostering cross-functional communication to optimize feed-back and input towards high quality documents.
11. Maintain audit, SOP and training compliance.
Minimum university life science degree or equivalent is required. Advanced degree or equivalent education/degree in life sciences/healthcare is desirable. Fluent English (oral and written). HYDERABAD ONLY: • Masters with 3-5 years of relevant experience. • PhD or degree in medicine (MBBS/MD or Alternative medicine) with 1-3 years of relevant experience • ≥ 2 years medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge, plus strong knowledge of the medical writing processes. • Excellent communication skills (written, verbal, presentations) • Operational knowledge of clinical trial reporting. • Very good understanding of biostatistics principles. • Ability to prioritize and manage multiple demands and projects. • Good knowledge of and some experience in global regulatory environment and process (key regulatory bodies, key documents, approval processes, safety reporting requirements). • Ability to define and solve complex problems (“Problem-solver”) • Broad knowledge and future oriented perspective • Proven track record in matrix environment • Experience in contributing to global, cross functional projects. •